Early lessons from the implementation of universal respiratory syncytial virus prophylaxis in infants with long-acting monoclonal antibodies, Galicia, Spain, September and October 2023.

A monoclonal antibody for universal respiratory syncytial virus prophylaxis in infants has recently been licensed. We share our experiences of integrating nirsevimab into the regional immunisation programme in Galicia, Spain. After a 3-week hospital-based immunisation campaign with flexible individualised appointments and educational activities, nirsevimab uptake was 97.5% in the high-risk group, 81.4% in the catch-up group and 92.6% in infants born during the campaign. This successful implementation strategy can serve as a model and may inform other countries' programmatic deliberations.

COVID-19 vaccine effectiveness in children by age groups. A population-based study in Galicia, Spain.

BACKGROUND: Studies on vaccine effectiveness (VE) against COVID-19 in the pediatric population are outgoing. We aimed to quantify VE against SARS-CoV-2 in two pediatric age groups, 5-11 and 12-17-year-old, while considering vaccine type, SARS-CoV-2 variant, and duration of protection. METHODS: A population-based test-negative control study was undertaken in Galicia, Spain. Children 5-11-year-old received the Comirnaty® (Pfizer, US) vaccine, while those aged 12-17-year-old received the Comirnaty® (Pfizer, US) or SpikeVax® (ModernaTX, Inc) vaccine. Participants were categorized into unvaccinated (0 doses or one dose with <14 days since vaccination), partially vaccinated (only one dose with ≥14 days, or two doses with <14 days after the second dose administration), and fully vaccinated (two doses with ≥14 days after the second injection). Adjusted odds ratios (OR) and their 95% confidence intervals (CI) were estimated using multiple logistic regression models. VE was calculated as (1-OR) * 100. Stratified and sensitivity analyses were performed. RESULTS: In the fully vaccinated 5-11-year-old children, VE against the Omicron variant was 44.1% (95% CI: 38.2%-49.4%). In the fully vaccinated 12-17-year-old individuals, VE was 83.4% (95% CI: 81.2%-85.3%) against Delta and 74.8% (95% CI: 58.5%-84.9%) against Omicron. Comirnaty® and SpikeVax® vaccines showed a similar magnitude of VE against Delta [Comirnaty® VE: 81.9% (95% CI: 79.3%-84.1%) and SpikeVax® VE: 85.3% (95% CI: 81.9%-88.1%)]. Comirnaty® (Pfizer, US; VE: 79.7%; 95% CI: 50.7%-92.4%) showed a slightly higher magnitude of protection against Omicron than SpikeVax® (ModernaTX, Inc), yet with an overlapping CI (VE: 74.3%; 95% CI: 56.6%-84.9%). VE was maintained in all age subgroups in both pediatric populations, but it declined over time. CONCLUSIONS: In Galicia, mRNA VE was moderate against SARS-CoV-2 infections in the 5-11-year-old populations, but high in older children. VE declined over time, suggesting a potential need for booster dose schedules.

Effectiveness of COVID-19 vaccine booster in the general population and in subjects with comorbidities. A population-based study in Spain.

BACKGROUND: Research on the effectiveness of COVID-19 booster-based vaccine schedule is ongoing and real-world data on vaccine effectiveness (VE) in comorbid patients are limited. We aimed to estimate booster dose VE against SARS-CoV-2 infection and COVID-19 severity in the general population and in comorbid patients. METHOD: A retrospective test-negative control study was undertaken in Galicia-Spain (December 2020-November 2021). VE and 95% confidence interval (CI) were estimated using multivariate logistic regression models. RESULTS: 1,512,415 (94.13%) negative and 94,334 (5.87%) positive SARS-CoV-2 test results were included. A booster dose of COVID-19 vaccine is associated with substantially higher protection against SARS-CoV-2 infection than vaccination without a booster [VEboosted = 87% (95%CI: 83%; 89%); VEnon-boosted = 66% (95%CI: 65%; 67%)]. The high VE was observed in all ages, but was more pronounced in subjects older than 65 years. VE against COVID-19 severity was analyzed in a mixed population of boosted and non-boosted individuals and considerable protection was obtained [VE: hospitalization = 72% (95%CI: 68%; 75%); intensive care unit administration = 83% (95%CI: 78%; 88%), in-hospital mortality = 66% (95%CI: 53%; 75%)]. Boosted comorbid patients are more protected against SARS-CoV-2 infection than those who were non-boosted. This was observed in a wide range of major diseases including cancer (81% versus 54%), chronic obstructive pulmonary disease (84% versus 61%), diabetes (84% versus 65%), hypertension (82% versus 65%) and obesity (91% versus 67%), among others. CONCLUSIONS: A booster dose of COVID-19 vaccine increases the protection against SARS-CoV-2 infection and COVID-19 severity in the general population and in comorbid patients.

Evaluation of BNT162b2 Vaccine Effectiveness in Galicia, Northwest Spain.

Investigating vaccine effectiveness (VE) in real-world conditions is crucial, especially its variation across different settings and populations. We undertook a test-negative control study in Galicia (Northwest Spain) to assess BNT162b2 effectiveness against acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as well as COVID-19 associated hospitalization, intensive care unit (ICU) admission and mortality. A total of 44,401 positive and 817,025 negative SARS-CoV-2 test results belonging to adults were included. Adjusted odds ratios of vaccination and their 95% confidence interval (CI) were estimated using multivariate logistic-regression models. BNT162b2 showed high effectiveness in reducing SARS-CoV-2 infections in all age categories, reaching maximum VE ≥ 14 days after administering the second dose [18-64 years: VE = 92.9% (95%CI: 90.2-95.1); 65-79 years: VE = 85.8% (95%CI: 77.3-91.9), and ≥80 years: VE = 91.4% (95%CI: 87.9-94.1)]. BNT162b2 also demonstrated effectiveness in preventing COVID-19 hospitalization for all age categories, with VE more pronounced for those aged ≥80 years [VE = 60.0% (95%CI: 49.4-68.3)]. Moreover, there was a considerable reduction in ICU admission [VE = 88.0% (95%CI: 74.6-95.8)] and mortality [VE = 38.0% (95%CI: 15.9-55.4)] in the overall population. BNT162b2 showed substantial protection against SARS-CoV-2 infections and COVID-19 severity. Our findings would prove useful for systematic reviews and meta-analysis on COVID-19 VE.

Eficiencia del programa de seguimiento farmacoterapéutico de antipsicóticos parenterales de acción prolongada en el área sanitaria de Santiago de Compostela / Efficiency of a pharmaceutical care program for long-acting parenteral antipsychotics in the health area of Santiago de Compostela

En el área sanitaria de Santiago de Compostela, el subgrupo terapéutico "otros antipsicóticos" era el quinto en mayor gasto extrahospitalario en el año 2013, correspondiendo más de la mitad a la risperidona y paliperidona parenterales de acción prolongada. La implantación de un programa de seguimiento farmacoterapéutico basado en la gestión por procesos y en la coordinación de actuaciones entre profesionales sanitarios de ambos niveles asistenciales supuso, en 12 meses un ahorro para la organización de 636.391,01 €, para el paciente de 16.767,36 € en aportaciones y 9.008 desplazamientos a la oficina de farmacia. Este trabajo muestra la eficiencia del programa facilitado por tratarse de un área de gestión integrada y utilizar la historia clínica única y prescripción electrónica, elementos que posibilitan la implantación futura de programas similares. Los nuevos registros y actuaciones asistenciales permitirán una evaluación fiable de su efectividad en relación a la adherencia terapéutica, recaídas y hospitalizaciones

In the healthcare area of Santiago de Compostela (Spain), the therapeutic subgroup "other antipsychotics" represented the fifth largest outpatient expenditure in 2013. More than half of this expenditure corresponded to long-acting parenteral forms of paliperidone and risperidone. Over a 12-month period, the implementation of a pharmaceutical care program based on process management and coordination of actions between health professionals in both levels of care represented savings of € 636,391.01 for the organization and a direct saving of € 16,767.36 and 9,008 trips to the pharmacy for patients. This study shows the efficiency of the program, which was facilitated by its situation in an area of integrated management and the use the unified medical records and electronic prescription, elements that will enable the future implementation of similar programmes. The new registries and healthcare interventions will allow reliable evaluation of their effectiveness in terms of treatment adherence, relapses and hospitalizations

Impact of a pharmacotherapeutic programme on control and safety of long-term anticoagulation treatment: a controlled follow-up study in Spain.

BACKGROUND: In patients undergoing oral anticoagulation treatment, correct control of the international normalized ratio (INR) is necessary. This study sought to assess the effectiveness of a pharmacotherapeutic follow-up programme (PTP) on achieving an optimal INR range, reducing the need for rescue medications and for monitoring the development of possible adverse events associated with poor oral anticoagulation therapy control (haemorrhagic events and thromboembolic disease). OBJECTIVE: The aim of this study was to evaluate the effectiveness of a PTP targeted at the anticoagulated patient to ensure proper self-control of anticoagulation. METHODS: This was a prospective, controlled, multicentre cohort study conducted at four primary care centres in Galicia (northwest Spain), covering a group of patients receiving anticoagulation treatment exposed to pharmacotherapeutic follow-up by a primary care pharmacist (n = 272), and a concurrent control group (n = 460). The intervention consisted of a patient health-education programme plus activities involving collaboration with the physician. The educational intervention exposure period was 12 months (starting from February 2006 and finishing in February 2007), during which time a minimum of one INR determination per month was performed. To assess the quality of haematological control, the British Committee for Standards in Haematology criteria were used, namely (i) 50% or more determinations per patient within a range of 0.5 units above or below the target INR; and (ii) 80% or more determinations per patient within a range of 0.75 units above or below the target INR. As an indicator of correct control of coagulation, we also assessed the occurrence of oral anticoagulation therapy-related adverse events, such as active bleeding, haematomas (jointly referred to as haemorrhagic events) and thromboembolic events. Depending on the type of response variable, negative binomial regression or Cox proportional risks models were fitted. RESULTS: Compared with the control group, the PTP managed to improve correct INR ranges by (i) 25% (relative risk [RR] = 0.75; 95% CI 0.69, 0.82) in terms of the number of patients who had their determinations within ±0.5 units of the target range; and (ii) 26% (RR = 0.74; 95% CI 0.67, 0.81) in terms of the number of patients who had their determinations within ±0.75 units of the target range. Patients belonging to the intervention group registered a 75% reduction in bleeding (hazard ratio [HR] = 0.25; 95% CI 0.18, 0.36). For every 3.27 patients exposed to the PTP, one event would be prevented (number needed to treat = 3.27; 95% CI 2.73, 4.07). CONCLUSIONS: Including patients receiving oral anticoagulant treatment in a PTP enhances INR control, efficacy and safety of treatment, and efficiency of primary healthcare services.